Examination of Witnesses (Questions 580-599)|
TUESDAY 11 MARCH 2003
580. Who should be responding to the media?
The media campaigns are anti everything really, are they not?
(Dr Miller) It depends really what the question is.
I have to front quite a lot of media issues but that relates to
the evidence upon which a vaccine's safety has been endorsed.
If it is a question of policy, why the Department of Health is
not providing vaccines separately rather than together, very much
a policy issue, I see that down to the Department of Health. The
manufacturers have a difficult role to play here because even
individuals might get accused of having conflicts of interest.
They have been involved in the introduction of the vaccine and
are now conspiring to keep its dangers away from the public. That
is very much more so with the vaccine manufacturers, but they
can provide an important role in ensuring that professional groups
have access to information. It is quite difficult to have all
the information at your fingertips and having well researched
sets of data available not only for an individual like myself,
because I am aware of the data, but other professional groups
who can be brought together and spokesmen identified. For instance,
a group has been brought together on MMR where there is a particular
issue. There are lead individuals who will make themselves available
to the press with a paediatric or general practice background
and they having access to readily available information is something
which is very important but has actually arisen out of the MMR
581. We heard about DEFRA suddenly coming into
the frame. I have to say that came as a surprise for me and may
have come as a surprise to some others. Do you feel they have
any role or should this actually be watched much more firmly in
(Dr Chatfield) My personal view is that it should
be lodged more firmly in the DOH. There are clearly environmental
issues potentially about releasing genetically modified organisms.
At the moment it sits with the Department of the Environment to
make that assessment. The issue comes with having a very clear
remit about what they are doing because at the moment we have
different groups reviewing different issues. It appears that another
group is now involved looking at the safety aspects in the human
subjects as well and that has become something we have had to
respond on in questions to DEFRA. We just need to have firm remits
for what each of these groups is doing in terms of their place
in the review process.
582. Do you think this might be a commitment
that the HPA would take on board?
(Dr Chatfield) Potentially.
(Dr Miller) A commitment in relation to evaluating
the environmental impact of live vaccine?
(Dr Miller) Clearly there would be expertise available
within the Health Protection Agency and the ability possibly to
set up some surveillance studies. I do not see it taking the lead
in establishing the regulatory framework. That has to come from
the Medicines Control Agency and if there are bodies outside the
Medicines Control Agency who are being required to look at safety
issues in human subjects, there is the potential there for confusion.
It needs to be concentrated within the regulatory agency, which
could tap into appropriate expertise as it exists with very clearly
defined remits and terms of reference.
584. What are your views on establishing a no-fault
compensation scheme for the fortunately small number of individuals
who suffer from side-effects as a result of vaccination? What
are the advantages and disadvantages in your view?
(Dr Miller) Is this over and above what exists in
relation to the existing vaccine damage payments scheme and the
availability individuals have through the law courts to claim
for compensation under consumer law, which does not require negligence
on the part of a manufacturer? Another scheme in addition to those
585. The current one does imply fault.
(Dr Miller) In relation to the consumer protection
law under which, for instance, the MMR litigation is being brought,
no question of fault is necessarily implied there. That does require
you to go through the legal process. Under the vaccine damage
payment scheme which exists already, whereby individuals who are
deemed to have suffered side-effects as a result of vaccination
are eligible to receive compensation, the sum is a maximum of
£100,000. That has been in place for some years. The amount
has increased. Clearly the requirement there is to establish causality.
Are you thinking of a wider system whereby anybody who suffers
an adverse event after vaccination would be liable to have compensation,
whether or not fault had been or actual causality had been established.
586. One would have to establish causality.
(Dr Miller) You could argue that the scheme we have
does not pay enough and maybe the criteria could be revisited
in relation to how much is paid to individuals who suffer side-effects.
However, there is that scheme in existence.
587. Who funds that? Is that government?
(Dr Miller) Yes. The decision about whether or not
a particular child is suffering an adverse event is made by medical
assessors who have no relationship to the Joint Committee on Vaccination,
licensing authority or the Department of Health. It is run independently.
(Mr Kingston) The current scheme is funded by the
Department for Works and Pensions, which we think actually probably
has some merit to it; to have a scheme not funded either by the
Department of Health who are buying the vaccines and setting the
policy or possibly also by the manufacturers. The advantages of
the current scheme are that it does provide financial compensation
up to a ceiling which some would say is relatively low. It provides
it very quickly without imposing a terrific burden of proof on
people who allegedly are suffering as a result of having a vaccine.
You have somebody in trouble and they get some relatively easy
assistance. At the other end of the scale, if somebody felt they
had been damaged by a vaccine which was incorrectly or negligently
produced, then of course they have all the liberties to take a
case against a manufacturer. We in UVIG think those two possibilities
for compensation do quite a good job at covering all the various
needs people might legitimately expect if we are asking them to
participate in a public health scheme where, sure, they get individual
benefits from taking the vaccine, but we also need to bear in
mind that society as a whole benefits when we do get vaccine coverage
up above the so-called herd immunity rate.
588. You all clearly seem to think that the
current system is absolutely fine. Do you have any suggestions?
Is it possible to improve it or is it absolutely perfect? How
could it be improved?
(Dr Miller) The issue of whether the amount is adequate.
If you are looking at compensation for lifetime loss of function,
as may happen after polio vaccine, one can question whether that
is enough. The amount has been raised. I am not sure why it was
put at £100,000 as opposed to something higher. Perhaps that
could be revisited, but in principle that is the right way to
do it, together with the recourse to litigation for those who
believe they have been suffering from effects but perhaps would
not be eligible for compensation under this scheme.
589. Do you think that the burden of proof for
causality is about right as it is at present or is it too onerous
for the current compensation scheme?
(Dr Miller) The information about who has been compensated
and what the evidence was of causal association is not widely
available. Certainly I have not seen detailed descriptions of
cases which have been awarded compensation. It is not put in the
public domain, certainly it is not data which are regularly reviewed,
for instance by the Joint Committee on Vaccination and Immunisation.
I believe it is very much down to the views of individual medical
assessors and a small panel. I cannot answer that one.
590. Are there any cases? Presumably there are
people who have been compensated.
(Dr Miller) Yes. Many more apply that receive compensation
that I am aware of.
Lord Rea: Yes, I know of numbers who have applied
and been turned down and feel rejected and rather aggrieved. They
feel sure themselves that there was a connection, but in fact
the evidence does not bear up.
591. Flu pandemics. These tend to originate
in South East Asia and sweep across the world. We have heard quite
a lot of evidence to suggest that really these things arise so
rapidly and then spread so rapidly that there is little chance
of both developing an appropriate vaccine and producing it and
getting it to populations in time for it to have much effect.
Would you agree that this is currently the case and is there anything
we can do about it?
(Mr Kingston) UVIG would agree this is currently the
case. The most practical thing to be done about it would be to
increase the recurring medical demand for vaccine in a non-pandemic
year in our view. The recurring medical demand for vaccines in
the UK at the moment under current policy is 12 million doses
per annum. Clearly if you suddenly want 60 million doses, that
is quite a magnitude of change. Most practically, there are groups
at the European level and in the States where they have probably
gone a little further, where policy has shifted to say rather
than 65 years and above, let us look at 50 years and above. There
are health economics data to suggest that even in a non-pandemic
year going to 50 years and above catches so many of your at risk
groups for the flu vaccineasthmatics, coronary heart disease
patients, diabeticsthat it is not an unreasonable medical
intervention to make anyway and it would simultaneously have the
effect of at least doubling the regular supply of vaccines in
592. That doubles your production facilities
but it does not do anything about the development time taken for
a new vaccine for a new strain.
(Mr Kingston) Correct; yes.
593. Is that a timetable which is feasible?
(Mr Kingston) Once the actual viral component of the
vaccine is identified, we are then in the timetable I alluded
to earlier on, which tends to be: start growing the virus in April
ending up with finished vaccine ready for administration at the
earliest in August. From the UVIG companies' point of view, we
see no way of accelerating that process significantly.
(Dr Chatfield) To some extent that depends on the
virus itself. There are issues each year in terms of manufacturing
yields, in terms of length of time it may take to culture the
virus, etcetera. One of the things which could be considered is
to look at new technologies for pandemic type vaccines because
it is clear that, considering we are talking about the A strains,
there are some new technologies emerging. There are groups now
who are working on vaccines which are not based on surface antigen,
(on which current vaccines are based) which are based on the nuclear
protein or the matrix protein where you get broad protection across
strains. It is by a different mechanism of immunity, but the really
important thing about it is that you could produce them as a conventional
protein peptide type vaccine and you could actually start to stockpile
these types of vaccines because you are then not reliant on producing
a new vaccine each time a new A strain comes along. I think from
this perspective that there should be a focus on this type of
technology as well, given the issues we have heard about with
the current vaccines.
Lord Oxburgh: That is very interesting; thank you.
594. Is anyone doing that work?
(Dr Chatfield) A couple of US companies are looking
at that sort of work in terms of looking at presenting the M protein
in a virus-like particle, but it is a virus-like particle which
does not rely on eggs to grow in or mammalian cells; you can grow
it in bacteria which makes a much simpler production process.
595. Is this something the government might
think about funding? It sounds as though it would bring benefits
(Dr Chatfield) There are now blossoming technologies
where it is right to start the funding process.
596. Is there sufficient collaboration with
China in view of the fact that the majority of flu strains do
come out of that part of the world? Is there sufficient collaboration
with the Chinese as to what is happening within China in the pig,
chicken, duck, human population?
(Dr Miller) The surveillance side is very good: WHO,
collaborating laboratories, rapidly identify. That side is okay.
The problems are very much the capacity, turning up the volume
suddenly and being able to have technologies which allow you to
have heterologous protection rather than strain specific protection.
597. One of the big problems about flu is that
you can prepare all your vaccines and then it never happens.
(Dr Miller) Yes. We have quite a good flu surveillance
system in the UK, actively looking for isolates in individuals
presenting with flu-like illness. Active surveillance is going
on so new strains are picked up very quickly in the UK. Internationally
the surveillance is good.
598. My last question is on communicable disease
as a global phenomenon, of which flu is one, I suppose, and the
control mechanisms. Possibly one should have a global outlook
here. Does the vaccine industry and the United Kingdom Government
have a sufficiently global outlook in relation to vaccine research
and development? If not, how should this be achieved?
(Dr Chatfield) I certainly think that the UK vaccine
industry has a global outlook. As a company we have to develop
vaccines for the global market. We could not justify developing
these vaccines for the UK market alone, so for that reason, the
UK vaccine industry has to be a global industry.
599. What are the problems that vaccine developers
have in meeting the demands of the various countries, in registering
vaccines and vaccine schedules and the rest? Is this a major problem
for getting vaccines into countries which need them?
(Mr Kingston) It becomes a problem in designing the
clinical trials. This particularly applies to infant schedule
vaccines, which in one country may be administered at two, three,
four months of age and in another country it might be two, four
six; there are several different schedules, all with their own
arguments for and against. Clearly if you are going to test all
those in your clinical trial programme that adds to time, complexity
and expense. Beyond that, certainly within Europe, different stances
are taken by the different medical agencies, which are not new
to the pharmaceutical industry, so we know what we are dealing
with there, but unless you come up with a very new vaccine and
you get it licensed through the EMEA, you do have a period of
negotiation and dealing with different questions and sometimes
opposing perspectives through the Member States.
(Dr Chatfield) It comes back to some of the comments
I made earlier. In the US it is much easier because you are going
through one system and you are dealing with one regulatory authority.
The difficulties you have just alluded to in Europe are real in
terms of how those vaccines may end up being used despite the
centralised procedure, the additional work which you have to do
to make sure you can get those vaccines into the national vaccination
schedules or bought into in terms of some of the agencies that
will eventually provide these vaccines.